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Comparison of Patient Centered Outcomes for People With SCD in the Acute Care Setting (ESCAPED)

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ClinicalTrials.gov Identifier: NCT02411396
Recruitment Status : Completed
First Posted : April 8, 2015
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:

The Emergency Department has been the standard location where patients with Sickle Cell Disease (SCD) go to seek care for the treatment of acute painful events. Vaso- Occlusive Crisis (VOC) is the most common complication of SCD,

The purpose of this study is to compare patient centered outcomes for patients being treated for an uncomplicated VOC in Infusion Centers (IC) and Emergency Departments (ED) in four locations around the United States.


Condition or disease Intervention/treatment
Sickle Cell Disease Other: Patient Centered Outcomes

Detailed Description:

Emergency Department care is marked by long delays, lack of efficacy, and conflict. A sub-specialty Infusion Center staffed by expert clinicians and delivering individualized care can improve care quality while reducing costs. The study will examine whether care provided in an Infusion Center is more patient centered and efficient than care provided in an Emergency Department for adults with SCD and uncomplicated VOC.

Sites will prospectively enroll patients in VOC seen in participating centers from either the EDs or the ICs. Specific data from the acute visits (e.g. Times of arrival, time to first dose of analgesic, etc) will be captured. This study will compare: pain management, disposition of subjects (home or admission) and patient experiences of care delivery in both settings. Subjects will complete surveys/questionnaires to asses their experiences in the setting where care was provided.

The four sites to participate in the study are Baltimore, Maryland (Johns Hopkins Hospital), Cleveland, Ohio (Cleveland Medical Center), Milwaukee, Wisconsin (Medical College of Wisconsin), and Baton Rouge, Louisiana (Our Lady of the Lake Hospital). A maximum of 500 subjects will participate in the study. Participants will be enrolled for 18 months.


Study Type : Observational
Actual Enrollment : 483 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Centered Outcomes Research Institute (PCORI) ESCAPED Study: Comparison of Patient Centered Outcomes for People With SCD in the Acute Care Setting
Actual Study Start Date : April 2016
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
VOC in patients with SCD
This is an observational study comparing patient centered outcomes for patients treated for uncomplicated VOC in ICs and EDs.
Other: Patient Centered Outcomes
Comparison of treatment in patients with SCD in VOC in acute care settings




Primary Outcome Measures :
  1. Time from arrival to center to time first dose of parenteral pain medication administered [ Time Frame: Within 6 hours after arrival ]
    Comparing time to medicate in the ED versus the Infusion Center


Secondary Outcome Measures :
  1. Outcome of acute visit [ Time Frame: Day 1 ]
    Admission, emergency department or discharge to home

  2. Pain level after first dose of pain medication administered [ Time Frame: 30 minutes after administration ]
    The pain level of patient will be assessed on a pain score survey tool administered after the first dose

  3. Patient reported satisfaction [ Time Frame: within 72 hours of acute visit ]
    Survey to capture patient comments on treatment received in facility

  4. Patient reported perceptions of risk from visit [ Time Frame: within 72 hours of acute visit ]
    Survey to capture patient concerns for safety while present in facility



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult subjects with SCD inclusive of genotypes homozygous and compound heterozygous sickle hemoglobin. In the United States, SCD primarily afflicts African-American and Hispanic-American populations. Patients will be enrolled prior to a vaso-occlusive crisis and data will be collected from their acute visit(s) at either the Emergency Department or at an Infusion center (4 participating sites).
Criteria

Inclusion Criteria:

  • Confirmed Sickle Cell Disease patients who live within 60 miles of the study center or who already receive regular care at the participating centers.

Exclusion Criteria:

  • Stable patients who have been on chronic transfusion therapy and have not had a painful episode within two years of enrollment.
  • Patients who are pregnant.
  • Patients who are unwilling or unable to sign consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02411396


Locations
United States, Louisiana
Our Lady of the Lake Hospital
Baton Rouge, Louisiana, United States, 70809
United States, Ohio
Cleveland Medical Center at University Hospitals
Cleveland, Ohio, United States, 44106
United States, Wisconsin
Medical College of Wisconsin, Blood Center
Milwaukee, Wisconsin, United States, 53201
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Sophie Lanzkron, MD, MHS Johns Hopkins University, Division of Hematology

Publications:
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02411396     History of Changes
Other Study ID Numbers: IRB00054029
PCORI-1403-11888 ( Other Grant/Funding Number: PCORI )
First Posted: April 8, 2015    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn